A Multicentre Trial of Nerve-Spring Radical Hysterectomy vs. Radical Hysterectomy for Cervical Cancer

Cervical Cancer Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01886508
• Other study ID #: NCT00270426
• Status: Not yet recruiting
• Phase: N/A
• First received: September 25, 2012
• Last updated: July 19, 2013
• Start date: July 2013
• Est. completion date: December 2020

Study information

• Verified date: May 2013
• Source: Nanfang Hospital of Southern Medical University
• Contact: Chenlin Chen, M.D.,Ph.D.
• Phone: +8602062787947
• Email: chenchunlinrct[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The investigators designed this multicentre randomized study to investigate the clinical benefits of nerve-spring radical hysterectomy for cervical cancer. Patients with FIGO stage Ia2, Ib1, IIa1 and FIGO stage Ib2, IIa2 after neoadjuvant chemotherapy are randomized to either nerve-spring radical hysterectomy or radical hysterectomy. The primary endpoint are urodynamic outcome including maximum flow rate, residual volume, maximum vesical compliace, cystomctric capacity at first desire, and maximum cystomctric capacity. A total 240 patients (120 per treatment arm) are planned to accrue for this study within 7 years.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: December 2020
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 17 Years to 60 Years

Eligibility

Inclusion Criteria:

1. FIGO(2009) stage Ia2, Ib1, and IIa1 Untreated cervical cancer OR FIGO(2009) stage Ib2 and IIa2 cervical cancer that possible to surgery after neoadjuvant chemotherapy

2. Possible to radical hysterectomy or nerve-spring radical hysterectomy

3. Age: 17 to 60 years

4. No complication during operation

5. Written informed consent

Exclusion Criteria:

1. patients who underwent radiotherapy

2. Pathologically diagnosed Pathologically diagnosed squamous carcinoma, Small Cell Carcinoma, Small Cell Carcinoma

3. Patients who have uncontrolled diabetes or uncontrolled hypertension

4. patients with neurogenic bladder dysfunction

5. patients with uterine prolapse

6. Patients with psychiatric illness

7. Patients who have active infection

8. Patients who have had heart failure, unstable angina, or myocardial infarction within the past 6 months

9. Patients who are unable to undergo radical hysterectomy for complication of excessive obesity, liver cirrhosis, or bleeding tendency

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Nerve-spring radical hysterectomy
Nerve-spring radical hysterectomy that is reserve some pelvic autonomic nerves during radical hysterectomy. Reserve hypogastric nerve trunk during dissecting cardinal ligament. Reserve pelvic splanchnic nerve trunk during exsecting uterosacral ligament. Reserve bladder nerve of pelvic plexus during dissecting vesicouterine ligament.
• radical hysterectomy
Radical hysterectomy is Piver III hysterectomy and Q-M classification Type C1 hysterectomy.

Locations

Country	Name	City	State
China	Southern Medical University, China	Guangzhou	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	China People's Liberation Army No. 152 Centre Hospital, Gui Yang Maternal and Child Health Hospital,China, Tumor Hospital of Xin Jiang Medical University,China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum flow rate measured by Urodynamic at 6 months postoperative		on 6 months postoperative	No
Primary	residual volume measured by Urodynamic at 6 months postoperative		on 6 months postoperative	No
Primary	maximum vesical compliace measured by Urodynamic at 6 months postoperative		on 6 months postoperative	No
Primary	cystometric capacity at first desire measured by Urodynamic at 6 months postoperative		on 6 months postoperative	No
Primary	maximum cystometric capacity (MCC) measured by Urodynamic at 6 months postoperative		on 6 months postoperative	No
Secondary	Time (days) to residual urine volume less than 100ml postoperative		from operation to residual urine volume less than 100ml, assessed up to 30 days	No
Secondary	time (hours) to break wind postoperative		from operation to have the first break wind, assessed up to 72 hours	No
Secondary	time (hours) to defecation postoperative		from operation to have the first defection, assessed up to 72 hours	No
Secondary	Number of participants with adverse events		From date of operation until the date of first documented adverse event or date of death from any cause, whichever came first, assessed up to 5 years	Yes
Secondary	Score of MHU rating scales at 6 months postoperative		on 6 months postoperative	No
Secondary	overall survival		From date of operation until the date of death from any cause, assessed up to 5 years	Yes
Secondary	progression-free survival		From date of operation until the date of relapse or date of death from any cause, whichever came first, assessed up to 5 years	Yes
Secondary	Score of C-30 life quality rating scales at 6 months postoperative		on 6 months postoperative	No
Secondary	Score of CX-24 life quality rating scales at 6 months postoperative		on 6 months postoperative	No